Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study
1 other identifier
interventional
100
1 country
11
Brief Summary
This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2021
CompletedFirst Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
March 21, 2024
March 1, 2024
5 years
October 13, 2021
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of AESI
death, neoplasms or malignancies in tissues or organs, Immune response including exacerbation or new outbreaks of previous autoimmune diseases, Other delayed AE related to Cellgram LC)
For 5 years
Rate of Liver transplant
Liver transplant
For 5 years
Study Arms (1)
Cellgram-LC
EXPERIMENTALPatients with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.
Interventions
Eligibility Criteria
You may qualify if:
- Those who participated in PMC-P-07 clinical trials and received Cellgram-LC
- Those who voluntarily agreed in writing to participate in this investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Soonchunhyang University Hospital
Bucheon-si, South Korea
Soonchunhyang University Hospital
Cheonan, South Korea
Gangwon National University Hospital
Chuncheon, South Korea
Hallym Univ. Medical Center
Chuncheon, South Korea
Gangneung Asan Hospital
Gangneung-si, South Korea
Eunpyeong St. Mary's Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Yongin Severance Hospital
Yŏngin, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moonyoung Kim
Wonju Severance Christian Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 26, 2021
Study Start
August 24, 2021
Primary Completion (Estimated)
August 24, 2026
Study Completion (Estimated)
March 31, 2028
Last Updated
March 21, 2024
Record last verified: 2024-03